Required Elements and Documentation

I. General Requirements

No investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases, or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

A. Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject:

A statement that the study involves research, an explanation of the purpose(s) of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental;

A description of any reasonably foreseeable risks or discomforts to the subject;

A description of any benefits to the subject or to others which may reasonably be expected from the research;

A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

For research involving more than minimal risk, an explanation as to whether any compensation is provided and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and

A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits which the subject is otherwise entitled to receive for participation up to the point of their termination.

B. Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:

A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.

Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subjects' consent.

Any additional costs to the subject that may result from participation in the research.

The consequences of the subject's decision to withdraw from the research, and procedures for orderly termination of participation by the subject.

A statement that significant new findings developed during the course of the research which may relate to the subjects' willingness to continue participation will be provided to the subject.

The approximate number of subjects involved in the study.

C. The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

The research involves no more than minimal risk to the subjects;

The research could not practicably be carried out without the waiver or alteration; and

Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

D. The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
(i) programs under the Social Security Act, or other public benefit or service programs;
(ii) procedures for obtaining benefits or services under those programs;
(iii) possible changes in or alternatives to those programs or procedures; or
(iv) possible changes in methods or levels of payment for benefits or services under those programs; and

The research could not practicably be carried out without the waiver or alteration.

E. The informed consent requirements in these regulations are not intended to preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.

F. Nothing in these regulations is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law.

II. Documentation of Informed Consent

A. Except as provided in paragraph C of this section (below), informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

B. Except as provided in paragraph C of this section (below), the consent form may be either of the following:

A written consent document that embodies the elements of informed consent required by the Code of Federal Regulations. This form may be read to the subject or the subject's legally authorized representative, and the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or

A "short form" written consent document stating that the elements of informed consent required by the Code of Federal Regulations have been presented orally to the subject or representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the "short form."

C. The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In situations where the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.